FDA 510(k)

POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (100 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABP

K-Number: K990210 · 1999-03-29

Decision Date1999-03-29

Product CodeLYY

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (100 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABP is the device name listed in this FDA 510(k) record. The listed applicant is Mexpo Intl., Inc.. It received FDA 510(k) clearance on 1999-03-29 under 510(k) number K990210. The device is classified under product code LYY. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (100 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABP?

POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (100 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABP is a medical device that received FDA 510(k) clearance on 1999-03-29. The listed applicant is Mexpo Intl., Inc.. The 510(k) number is K990210.

When did POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (100 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABP receive FDA 510(k) clearance?

POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (100 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABP received FDA 510(k) clearance on 1999-03-29, under 510(k) number K990210.

Who is the listed applicant for POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (100 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABP?

The FDA 510(k) record lists Mexpo Intl., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (100 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABP?

The FDA product code for POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (100 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABP is LYY.

Related Clinical Trials

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Other records listing Mexpo Intl., Inc. as applicant

K992337BLOSSOM POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM 50 MCGM OR LESS OF TOTAL WATER EXTRACTA K984040BLOSSOM POWDERED LATEX EXAMINATION GLOVES K974782LOW PROTEIN POWDER FREE LATEX EXAMINATION GLOVES

Related Devices (Code: LYY)

K250069Powder Free Natural Rubber Latex Examination Gloves – Blue, Non-Sterile and Protein Claim Of 50 Micrograms per dm2 Or Less ProteinComfort Rubber Gloves Industries Sdn. Bhd.K240266Latex Examination Glove Powder Free (Ocean Blue and Natural White)Sri Trang Gloves (Thailand) Public Company Limited K230573Powder Free Latex Patient Examination Glove, Black Colored, Non-sterile, with Protein Content labeling Claim (Contains 50 ug per dm2 of glove or less of Total Water Extractable Protein)Kossan International Sdn Bhd K223298Sterile Latex Examination Gloves Powder Free (S, M, L, Extra L)Shandong Intco Medical Products Co, Ltd.K222612Powder-Free Latex examination glovesGuangdong Kingfa Sci. & Tech.Co., Ltd.K221667Non Sterile Powder Free Latex Examination GloveNew Era Medicare Sdn. Bhd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.